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Handy Solutions 31232

by Navajo Manufacturing Company Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00024291312321 UDI-DI Date30 Sep 2025ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1181-2026 FDA Class II initiated 26 Dec 2025

    Potential exposure of rodents and rodent activity in the distribution center.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Handy Solutions
Generic Name
Basic male condom, Hevea-latex
Model / Ref / Catalog
31232
Primary DI / UDI-DI
00024291312321
510(k) Number
FDA Product Code
HIS
GMDN Term
Basic male condom, Hevea-latex
Device Class
Class II
Regulation Number
884.5300
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K874383)

Other devices from Navajo Manufacturing Company Inc.

See all devices from Navajo Manufacturing Company Inc. →

Properties

  • Single Use
  • Contains Latex
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No